NCT04242706

Brief Summary

The study objective is to determine VAP (Ventilator Associated Pneumonia) baseline incidence in the ICU in patients receiving endotracheal tubes with evacuation lumen with and without Bactiguard coating. The study is randomized, prospective, controlled and blinded. All adult patients hospitalized in the ICUs from two tertiary hospitals (i.e.: Centre Hospitalier Universitaire Sart Tilman Liège , Centre Hospitalier Chrétien de Liège) and considered to be ventilated for more than 24 hours will be eligible to participate in the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

January 13, 2020

Last Update Submit

January 19, 2021

Conditions

Ventilator-associated Pneumonia

Outcome Measures

Primary Outcomes (1)

  • VAP incidence

    Ventilator Associated Pneumonia incidence

    Up to 28 days after inclusion

Secondary Outcomes (8)

  • Nosocomial infections

    Up to 28 days after inclusion

  • VAT incidence

    Up to 28 days after inclusion

  • Antibiotics consumption

    Up to 28 days after inclusion

  • Duration of ventilation

    Up to 28 days after inclusion

  • Duration of ICU and hospital stay

    Up to 28 days after inclusion

  • +3 more secondary outcomes

Other Outcomes (2)

  • Evaluation of microbial data

    Up to 28 days of intubation after inclusion

  • Evaluation of durability of the coating metals at the surface during use

    Up to 28 days of intubation after inclusion

Study Arms (2)

Control group

ACTIVE COMPARATOR

Endotracheal tube with evacuation lumen without Bactiguard coating.

Device: ETTEvac

Experimental group

EXPERIMENTAL

Endotracheal tube with evacuation lumen with Bactiguard coating.

Device: BIP ETTEvac

Interventions

ETTEvacDEVICE

Endotracheal tube with evacuation lumen without noble metal coating

Control group
BIP ETTEvacDEVICE

Endotracheal tube with evacuation lumen with noble metal coating

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • intubation with a study tube and a presumed duration of ventilation for more than 24h,
  • age \> 18 y,
  • signed informed consent

You may not qualify if:

  • tracheostomized patient
  • life expectancy less than 48h,
  • previous participation in the study
  • pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire Sart Tilman Liège

Liège, B-4000, Belgium

Location

Centre Hospitalier Chrétien de Liège and Centre Hospitalier Chrétien (CHC Clinique de l'Espérance)

Liège, Belgium

Location

Related Publications (1)

  • Damas P, Legrain C, Lambermont B, Dardenne N, Guntz J, Kisoka G, Demaret P, Rousseau AF, Jadot L, Piret S, Noirot D, Bertrand A, Donneau AF, Misset B. Prevention of ventilator-associated pneumonia by noble metal coating of endotracheal tubes: a multi-center, randomized, double-blind study. Ann Intensive Care. 2022 Jan 4;12(1):1. doi: 10.1186/s13613-021-00961-y.

    PMID: 34981245DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Benoit Misset, MD,Prof.

    CHU, Liege; Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blinded, the two devices have the same appearance.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Controlled study. Two interventions: 1. Endotracheal tube with evacuation lumen without Bactiguard coating. 2. Endotracheal tube with evacuation lumen with Bactiguard coating.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 27, 2020

Study Start

October 31, 2018

Primary Completion

May 8, 2020

Study Completion

May 8, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

BE(2)